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KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)
NCT04165798 · Merck Sharp & Dohme LLC
In plain English
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Official title
KEYMAKER-U01 Master Study: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, Pembrolizumab, and Chemotherapy, Alone or in Combination, in Participants With Non-small Cell Lung Cancer (NSCLC)
About this study
The following pembrolizumab substudies will evaluate the efficacy of different investigational agents in combination with pembrolizumab given in sequence or in combination with pembrolizumab PLUS chemotherapy:
* KEYMAKER-U01 Substudy 01A: A Phase 1/2, Umbrella Study With Rolling Arms of Investigational Agents, With Pembrolizumab With or Without Chemotherapy in Treatment-Naive Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01A) - NCT04165070
* KEYMAKER-U01 Substudy 2: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Treatment Naïve Patients with PD-L1 Positive Advanced Non-small Cell Lung Cancer (NSCLC) (MK-3475-01B) - NCT04165083
* KEYMAKER-U01 Substudy 3: A Phase 2, Umbrella Study with Rolling Arms of Investigational Agents in Combination with Pembrolizumab in Patients with Advanced Non-small Cell Lung Cancer (NSCLC) Previously Treated with anti-PD-(L)1 Therapy (MK-3475-01C) - NCT04165096
* KEYMAKER-U01 Substudy 01E: A Phase 2 Umbrella Study With Rolling Arms of Investigational Agents With or Without Chemotherapy in Combination With Pembrolizumab in Treatment of Participants With Newly Diagnosed Resectable Stages II-IIIB (N2) Non-small Cell Lung Cancer (NSCLC) (MK-3475-01E) - NCT06788912
* KEYMAKER-U01 Substudy 01F: A Phase 1b/2 Umbrella Study With Rolling Arms of Investigational Agents for Second-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations (MK-3475-01F) - NCT number pending
* KEYMAKER-U01 Substudy 01G: A Phase 2, Umbrella Study With Rolling Arms of Investigational Agents in Combination With Pembrolizumab With or Without Platinum-based Chemotherapy in Treatment-Naïve Participants With Stage IV Non-small Cell Lung Cancer (NSCLC) (MK-3475-01G) - NCT06731907
* KEYMAKER-U01 Substudy 01H: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants with Previously Treated Stage IV Nonsquamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01H) - NCT06780085
* KEYMAKER-U01 Substudy 01I: A Phase 2, Randomized, Umbrella Study With Rolling Arms of Investigational Agents in Participants With Previously Treated Stage IV Squamous Non-small Cell Lung Cancer (NSCLC) (MK-3475-01I) - NCT06780098
* KEYMAKER-U01 Substudy 01J: A Randomized Phase 2 Umbrella Study With Rolling Arms of Investigational Agents for First-line Treatment of Participants With Advanced or Metastatic Nonsquamous Non-small Cell Lung Cancer (NSCLC) With KRAS G12C Mutations (MK-3475-01J) - NCT number pending
Eligibility criteria
Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
* Has histologically- or cytologically-confirmed diagnosis of Stage IV squamous or nonsquamous NSCLC
* Has measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
* Has an active autoimmune disease that has required systemic treatment in the past 2 years
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
Study design
Enrollment target: 1065 participants
Age groups: adult, older_adult
Timeline
Starts: 2019-12-19
Estimated completion: 2032-02-13
Last updated: 2026-04-17
Interventions
Diagnostic Test: Tumor ImagingProcedure: Tumor Tissue CollectionProcedure: Blood Sample Collection
Primary outcomes
- • Programmed Cell Death-Ligand 1 (PD-L1) Tumor Expression Level: Tumor Proportion Score (TPS) <1% vs. TPS =1% (Up to approximately 1 month)
- • Tumor Histology Status: Squamous Non-small Cell Lung Cancer (NSCLC) vs. Nonsquamous NSCLC (Up to approximately 1 month)
Sponsor
Merck Sharp & Dohme LLC · industry
With: Daiichi Sankyo
Contacts & investigators
ContactToll Free Number · contact · Trialsites@msd.com · 1-888-577-8839
InvestigatorMedical Director · study_director, Merck Sharp & Dohme LLC
All locations (47)
Banner MD Anderson Cancer Center ( Site 0001)Completed
Gilbert, Arizona, United States
City of Hope ( Site 0014)Completed
Duarte, California, United States
UCSF Medical Center at Mission Bay ( Site 0007)Completed
San Francisco, California, United States
Georgetown University ( Site 0036)Completed
Washington D.C., District of Columbia, United States
University of Kentucky Markey Cancer Center ( Site 0019)Completed
Lexington, Kentucky, United States
MedStar Franklin Square Medical Center ( Site 0033)Completed
Baltimore, Maryland, United States
Massachusetts General Hospital ( Site 0003)Completed
Boston, Massachusetts, United States
Dana Farber Cancer Institute ( Site 0002)Completed
Boston, Massachusetts, United States
Oncology Hematology West, PC DBA Nebraska Cancer Specialists ( Site 0031)Completed
Omaha, Nebraska, United States
Dartmouth Hitchcock Medical Center ( Site 0016)Recruiting
Lebanon, New Hampshire, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0037)Completed
Hackensack, New Jersey, United States
Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0034)Completed
New York, New York, United States
Sanford Fargo Medical Center ( Site 0039)Recruiting
Fargo, North Dakota, United States
Cleveland Clinic Main ( Site 0006)Completed
Cleveland, Ohio, United States
Ohio State University Comprehensive Cancer Center ( Site 0015)Recruiting
Columbus, Ohio, United States
Abramson Cancer Center of the University of Pennsylvania ( Site 0010)Recruiting
Philadelphia, Pennsylvania, United States
Sanford Cancer Center ( Site 0038)Recruiting
Sioux Falls, South Dakota, United States
The University of Texas MD Anderson Cancer Center ( Site 0009)Recruiting
Houston, Texas, United States
Petz Aladar Megyei Oktato Korhaz ( Site 0062)Completed
Győr, Győr-Moson-Sopron, Hungary
Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0061)Completed
Szolnok, Jász-Nagykun-Szolnok, Hungary
Orszagos Koranyi Pulmonologiai Intezet ( Site 0060)Completed
Budapest, Hungary
Soroka Medical Center ( Site 0072)Completed
Beersheba, Israel
Rambam Health Care Campus-Oncology ( Site 0076)Completed
Haifa, Israel
Shaare Zedek Medical Center ( Site 0075)Recruiting
Jerusalem, Israel
Meir Medical Center ( Site 0071)Completed
Kfar Saba, Israel
Rabin Medical Center ( Site 0074)Completed
Petah Tikva, Israel
Chaim Sheba Medical Center ( Site 0070)Recruiting
Ramat Gan, Israel
Sourasky Medical Center ( Site 0077)Completed
Tel Aviv, Israel
Azienda Ospedaliera Universitaria Careggi ( Site 0173)Completed
Florence, Firenze, Italy
IRCCS Ospedale San Raffaele ( Site 0171)Completed
Milan, Italy
Policlinico Gemelli di Roma ( Site 0174)Completed
Roma, Italy
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Pluca i Klatki Pier ( Site 0151)Recruiting
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne-Early Clinical Trials Unit ( Site 0150)Completed
Gdansk, Pomeranian Voivodeship, Poland
Szpital Wojewódzki im. Mikoaja Kopernika w Koszalinie-Oddzial Dzienny Chemioterapii ( Site 0152)Active Not Recruiting
Koszalin, West Pomeranian Voivodeship, Poland
Seoul National University Bundang Hospital ( Site 0081)Completed
Seongnam-si, Kyonggi-do, South Korea
Severance Hospital ( Site 0080)Completed
Seoul, South Korea
Samsung Medical Center ( Site 0082)Completed
Seoul, South Korea
ICO L Hospitalet ( Site 0090)Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Clínic de Barcelona ( Site 0092)Recruiting
Barcelona, Spain
Hospital Universitario Quiron Madrid ( Site 0091)Recruiting
Madrid, Spain
Changhua Christian Hospital ( Site 0181)Recruiting
Changhua, Taiwan
Taipei Medical University Hospital ( Site 0180)Recruiting
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch ( Site 0182)Recruiting
Taoyuan District, Taiwan
COMMUNAL NONPROFIT ENTERPRISE CLINICAL CENTER OF ONCOLOGY, HEMATOLOGY, TRANSPLANTOLOGY AND PALLIATI ( Site 0463)Recruiting
Cherkasy, Cherkasy Oblast, Ukraine
Communal Non-Commercial Enterprise "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Reg ( Site 0460)Recruiting
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine
ME RIVNE REGIONAL ANTITUMOR CENTER ( Site 0461)Recruiting
Rivne, Rivne Oblast, Ukraine
Uzhhorod Multispecialty City Clinical Hospital ( Site 0462)Recruiting
Uzhhorod, Zakarpattia Oblast, Ukraine